Vocal Acoustic Biomarkers in Depression

NCT00844948 | Completed

• 2 other identifiers: 2008P0001105R44MH068950-03
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase II SBIR study will replicate pilot study methods establishing computer-automated methods for assessing depression severity using interactive voice response system technology and demonstrating feasibility of obtaining measures of depression severity and treatment response through vocal acoustic analysis of speech samples obtained over the telephone. The study will automate vocal acoustic analysis methods, evaluate applicability to other patient populations (non-English speakers, children/young adult, and geriatric), and further develop multivariate acoustic models to enhance biomarker sensitivity to treatment response and prediction of the response likelihood for individual patients.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Motoric and frequency-based change in the vocal acoustic properties of speech associated with clinical improvement measured by the Quick Inventory of Depressive Symptomatology - IVR (QIDS-IVR).

  baseline, week 4 & week 8

Secondary Outcomes (1)

• Multivariate logistic regression models of vocal acoustic properties optimized for sensitivity to treatment response and prediction of the response likelihood fitted to data obtained in NCT00407952.

  baseline, week 4, week 8

Study Arms (3)

Young adults (18-25 years old)

Young adults (18-25 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism.

Elderly (60-80 years old)

Elderly (60-80 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism.

Chinese speakers

Chinese speakers (Mandarin or Cantonese). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

English speaking: Young Adults, age 18-25; Elderly, age 60-80. Chinese speaking (Mandarin or Cantonese): age 18-80.

You may qualify if:

• Age 18 - 80.
• Written informed consent.
• Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
• Recently started to receive or about to start receiving treatment for MDD
• Quick Inventory of Depressive Symptomatology - Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit.

You may not qualify if:

• Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
• History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months.
• History or current diagnosis of dementia.
• Diagnosis or history of hypothyroidism.

Sponsors & Collaborators

• Center for Psychological Research, Madison, WI: lead
• Massachusetts General Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

South Cove Community Health

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• James C Mundt, PhD

  Center for Psychological Research, Training and Consultation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-04

Locations

US (2)